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首页> 外文会议>Rapra International Conference on Extractables Leachables for Pharmaceutical Products >THRESHOLDS AND BEST PRACTICES IN PARENTERAL AND OPHTHALMIC DRUG PRODUCTS
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THRESHOLDS AND BEST PRACTICES IN PARENTERAL AND OPHTHALMIC DRUG PRODUCTS

机译：肠胃外和眼科药品中的阈值和最佳实践

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The talk summarizes activities of the Product Quality Research Institute (PQRI) Working Group on Extractables and Leachables in Parenteral and Ophthalmic Drug Products (PODP). The Working Group includes pharmaceutical development scientists representing industry, government and academia. A Work Plan was approved 04 April 2008 entitled Development of Scientifically Justifiable Thresholds and Best Demonstrated Characterization Practices for Leachables and Extractables in Parenterals and Ophthalmic Drug Products (PODP). It was hypothesized that the "good science" best demonstrated practices that were established for the orally and inhaled nasal drug products (OINDP) pharmaceutical development process can be extrapolated to container closure systems for PODP. Threshold and best practices concepts can be integrated into a comprehensive process for characterizing container closure systems with respect to leachable substances and their associated impact on PODP safety. Threshold concepts that have been developed for safety qualification of leachables in OINDP can be extrapolated to the evaluation and safety qualification of leachables in PODP, with consideration of factors and parameters such as dose, duration, patient population and additional product dependent characteristics unique to various PODP types. The Work Plan will consider leachable thresholds for the following drug product categories based on FDA's high concern for safety relative to Package - Product interaction: Prefilled Syringe(PFS), Small and Large Volume Parenterals (SVP)/(LVP), Ophthalmic/Blow Fill Seal (BFS). Disposable systems (tank liners, storage containers, filters, tubing) should also be considered in the absence of defined and specific regulatory guidance. The hypothesis is being tested by a team of toxicologists and chemists. The chemistry team obtained various materials representative of typical PODP dosage forms for the purpose of demonstrating best practices for acquiring extractable data. A qualitative protocol was agreed upon by the Working Group, taking into considerations multiple solvents and headspace volatiles. A comprehensive list of extractables, derived from experience and literate searches were compiled by the team of toxicologists to enable a safety concern threshold to be explored based on small volume parenterals (SVP) large volume parenetersl (LVP) prefilled syringes and (PFS) and ophthalmic dosage forms. Currently, the acquisition of extractable data is ongoing, the initial results are being summarized and assessed in conjunction with proposed toxicological thresholds. The toxicological thresholds are proposed based on a classification strategy taking into consideration sensitizers, genotoxicants and irritants. A recommendations document will be drafted once a consensus is reached which will be submitted to the PQRI steering committee and regulatory authorities. Thresholds and Best Practice recommendations for SVP and PFS will be in the initial draft followed by LVP and ophthalmic to follow. This document is expected to be available in 2011 and is expected to result in improvement in quality and consistency of PODP and container closure characterization.
机译：谈话总结了产品质量研究所（PQRI）工作组在肠胃外和眼科药品（PODP）中的萃取物和鹿的工作组的活动。工作组包括代表行业，政府和学术界的制药开发科学家。 2008年4月4日批准了一项工作计划，题为科学合理的阈值的发展，最佳证明了鹿剂和眼科药品中的可脱色和萃取物的表征实践（PODP）。假设为口头和吸入的鼻药产品（OINDP）制药开发过程建立的“好科学”最佳证明实践可以推断为PODP的集装箱闭合系统。阈值和最佳实践概念可以集成到一个关于可浸出物质的集装箱闭合系统的综合过程中，以及它们对PODP安全的相关影响。为oindp中偏离的安全资格开发的阈值概念可以推断到PODP中鹿浸出物的评估和安全资格，考虑到各种PODP独一无二的剂量，持续时间，患者人口和其他产品依赖特征等因素和参数类型。工作计划将根据FDA对安全性相对于包装的高度关注，考虑以下药物产品类别的可恐怖阈值 - 产品相互作用：预填充注射器（PFS），小型和大卷肠胃（SVP）/（LVP），眼科/吹填充密封（BFS）。在没有定义和特定的监管指导的情况下，也应考虑一次性系统（坦克衬垫，储存容器，过滤器，管道）。假设是由毒理学家和化学家团队进行的测试。化学团队获得了各种材料代表典型的PODP剂型，以便展示获取可提取数据的最佳实践。工作组达成了一个定性议定书，考虑到多种溶剂和前空挥发物。毒理学家团队编制了源自经验和识字搜索的综合列表，以基于小卷肠胃大麻（SVP）预填充注射器和（PFS）和眼科和眼科和眼科和眼科和眼科和眼科和眼科和眼科和眼科进行探讨剂型。目前，正在进行中获取可提取数据，初始结果总结并与提出的毒理学阈值结合。基于考虑敏化剂，遗传毒剂和刺激物的分类策略提出了毒理学阈值。一旦达成共识，将提出建议文件，该委员会将提交给PQRI指导委员会和监管机构。 SVP和PFS的阈值和最佳实践建议将在初始草案中，其次是LVP和眼科遵循。本文件预计将于2011年提供，预计将导致PODP和集装箱闭合表征的质量和一致性提高。

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